n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

Jackie Bosch; Hertzel C Gerstein; Gilles R Dagenais; Rafael Díaz; Leanne Dyal; Hyejung Jung; Aldo P Maggiono; Jeffrey Probstfield; Ambady Ramachandran; Matthew C Riddle; Lars E Rydén; Salim Yusuf; ORIGIN Trial Investigators; Thure Krarup; Hans Jørgen Duckert Perrild; Christian Tobias Torp-Pedersen

doi:10.1056/nejmoa1203859

n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

Jackie Bosch, Hertzel C Gerstein, Gilles R Dagenais, Rafael Díaz, Leanne Dyal, Hyejung Jung, Aldo P Maggiono, Jeffrey Probstfield, Ambady Ramachandran, Matthew C Riddle, Lars E Rydén, Salim Yusuf, ORIGIN Trial Investigators, Thure Krarup, Hans Jørgen Duckert Perrild, Christian Tobias Torp-Pedersen

606 Citations (Scopus)

Abstract

Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

Original language	English
Journal	New England Journal of Medicine
Volume	367
Issue number	4
Pages (from-to)	309-18
Number of pages	10
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1203859
Publication status	Published - 26 Jul 2012

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10.1056/nejmoa1203859

https://www.nejm.org/doi/pdf/10.1056/NEJMoa1203859?articleTools=true

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Bosch, J., Gerstein, H. C., Dagenais, G. R., Díaz, R., Dyal, L., Jung, H., Maggiono, A. P., Probstfield, J., Ramachandran, A., Riddle, M. C., Rydén, L. E., Yusuf, S., ORIGIN Trial Investigators, Krarup, T., Perrild, H. J. D., & Torp-Pedersen, C. T. (2012). n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. New England Journal of Medicine, 367(4), 309-18. https://doi.org/10.1056/nejmoa1203859

Bosch, J, Gerstein, HC, Dagenais, GR, Díaz, R, Dyal, L, Jung, H, Maggiono, AP, Probstfield, J, Ramachandran, A, Riddle, MC, Rydén, LE, Yusuf, S, ORIGIN Trial Investigators, Krarup, T, Perrild, HJD & Torp-Pedersen, CT 2012, 'n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia', New England Journal of Medicine, vol. 367, no. 4, pp. 309-18. https://doi.org/10.1056/nejmoa1203859

@article{c80f0dbfdd1c4b0f93cdd6a5db1177ae,

title = "n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia",

abstract = "Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).",

author = "Jackie Bosch and Gerstein, {Hertzel C} and Dagenais, {Gilles R} and Rafael D{\'i}az and Leanne Dyal and Hyejung Jung and Maggiono, {Aldo P} and Jeffrey Probstfield and Ambady Ramachandran and Riddle, {Matthew C} and Ryd{\'e}n, {Lars E} and Salim Yusuf and Torp-Pedersen, {Christian Tobias} and Thure Krarup and Perrild, {Hans J{\o}rgen Duckert} and Torp-Pedersen, {Christian Tobias}",

year = "2012",

month = jul,

day = "26",

doi = "10.1056/nejmoa1203859",

language = "English",

volume = "367",

pages = "309--18",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "4",

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TY - JOUR

T1 - n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

AU - Bosch, Jackie

AU - Gerstein, Hertzel C

AU - Dagenais, Gilles R

AU - Díaz, Rafael

AU - Dyal, Leanne

AU - Jung, Hyejung

AU - Maggiono, Aldo P

AU - Probstfield, Jeffrey

AU - Ramachandran, Ambady

AU - Riddle, Matthew C

AU - Rydén, Lars E

AU - Yusuf, Salim

AU - ORIGIN Trial Investigators

AU - Krarup, Thure

AU - Perrild, Hans Jørgen Duckert

AU - Torp-Pedersen, Christian Tobias

PY - 2012/7/26

Y1 - 2012/7/26

N2 - Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

AB - Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

U2 - 10.1056/nejmoa1203859

DO - 10.1056/nejmoa1203859

M3 - Journal article

C2 - 22686415

SN - 0028-4793

VL - 367

SP - 309

EP - 318

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 4

ER -

n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

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